Home Forums TMF Management, Content & Processing Document Receive Date Reply To: Document Receive Date

Donna Dorozinsky

I agree with Jamie, when you start adding a multitude of dates you end up having to establish conventions for assigning dates. How do you define receipt. The date the monitor collects it, the date the monitor submits it for upload? It really becomes an honor system and how is that assessed? I recommend that companies assess timeliness based on records that have reliable document dates to measure timeliness. For example, study plans, protocols, Monitoring Visit Reports, ICFs, amendments, etc. If there are gaps in these documents, then that needs to be addressed as a priority. When you start looking at it across all documents you end up spending quite a bit of time explaining outliers. Essentially this is taking a risk based approach to timeliness.